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Monday, March 08, 2021

US Food and Drug Administration (USFDA)


UK general practitioners may use extra COVID-19 vaccine doses at discretion: NHS

December 18, 2020 9:02 am

The National Health Service (NHS) confirmed to Reuters that in a weekly webinar with NHS England on Thursday, clinicians were told they could use the sixth dose "at their discretion".

US regulator doubled warnings to Indian drugmakers last year

January 21, 2020 11:46 am

The sanctions may delay about 18 per cent of new products Indian companies were planning to introduce in the US, according to a report Monday from Crisil Ltd, the local unit of S&P Global Ratings.

USFDA warns Emcure Pharma for ‘failing’ to ‘adequately investigate’ injection sterility issues

August 17, 2019 2:32 am

The regulator has pointed out that Emcure “failed” to “adequately investigate” these sterility failures, adding that this is not the first time it uncovered such findings at the firm’s facility.

Glenmark Pharma gets tentative nod from USFDA for acne treatment drug

June 20, 2019 11:18 am

Glenmark Pharmaceuticals, USA, has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Clindamycin Phosphate Foam, 1 per cent, the company said in a BSE filing.

Teva Pharmaceutical: Shares rise after FDA approves new migraine drug

September 15, 2018 11:49 am

Shares of Teva, which rose 2.9 percent to close at $22.85 in regular trading, were up another 5.4 percent at $24 after hours.

Two DRL officials had sought removal of USFDA’s adverse observations

June 13, 2018 1:20 am

In the report, one of the USFDA inspectors wrote: “Mr Toshniwal and Mr Reddy Kallam requested that I remove the observations from the FDA-483.

USFDA observations: ‘Mosquitoes, gnats in Alkem plant; no quality control unit’

April 13, 2018 2:42 am

An FDA Form 483 is issued to a company’s management at the conclusion of an inspection if investigators find violations of US drug laws.

US FDA approves first digital ingestion tracking system drug to ensure prescriptions

November 14, 2017 6:49 pm

The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them.

USFDA to lift import alert on Vizag unit: Divi's Labs

November 02, 2017 3:01 pm

In March this year, Divi's Labs said USFDA had issued import alert under clauses 99-32 and 66-40, and a warning letter later for the Visakhapatnam facility for non-compliance of good manufacturing practice (GMP) norms.

Apple, Fitbit to join FDA program to speed health tech

September 27, 2017 8:24 pm

The Food and Drug Administration said Tuesday that it had selected nine major tech companies for a pilot program that may let them avoid some regulations that have tied up developers working on health software and products.